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HEALON EndoCoat PRO, REF: 10300012 (US/CAN) recallZ-3064-2026 · Johnson & Johnson Surgical Vision, Inc. · initiated Jul 31, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Johnson & Johnson Surgical Vision, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.

FDA root cause category: Device Design

What the company is doing

On 7/31/2026, correction notices were mailed to customers and distributors informing them of the following: Device Insertion Technique Clarification: If resistance is encountered during insertion, withdraw the cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding. Do not force the cannula through the incision, as this may increase the risk of unintended tissue injury, including, but not limited to corneal abrasion, iris trauma or Descemet s Membrane Detachment, which may require medical or surgical intervention to preclude serious injury. This investigation is currently ongoing, and we will notify users if any additional information comes to light. 1) Forward this notice to all surgeons using this device in your facility. 2) If any of the subject product has been transported to another facility/surgeon, contact that facility/surgeon and provide/forward this notice to them. 3) Keep a copy of this notice with the subject product. 4) Complete, sign, and return the Business Reply Form via email to [email protected] If you have questions or concerns with regard to this notification, please contact the firm's Global Post Market Safety Team at 1-877-266-4543, Option 2. Additional notices with additional affected devices to be sent in the future.

Recall details

Recall number
Z-3064-2026
Status
Open, Classified
Initiated by the company
Jul 31, 2026
Posted by the FDA
Aug 31, 2026
Recalling firm
Johnson & Johnson Surgical Vision, Inc.
Quantity
111,478
Product code
LZP
FDA submissions
P810031S078
Distribution
Worldwide - US Nationwide distribution including in the states of PA, AL, AZ, AR, CA, FL, IL, IN, IA, KY, LA, ME, MI, MN, MS, NJ, NY, NC, OH, OR, TN, TX, WA, WV, HI, CO, MD, VA, WI, ID, NH, SD, OK, MA, NM, DE, GA, SC, CT, NV, MO, RI, KS, ND and the countries of CA, BE, CH, DE, DK, ES, FR GB, HU, IS, IT, NL, NO, PT, SE.

Product description

HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)

Code information (models, lots, serial numbers)

REF/UDI-DI/Lot: 10300012/5050474755093/UA32232, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UP31203, UP31205; 10300016/5050474755116/UA32447, UA32448, UA32449, UB33008, UB33026, UB33082, UB33083, UB33175; 10301012/5050474755109/UB33014, UB33041, UB33057, UB33060, UB33100, UB33190; 10301016/5050474755123/UB33084, UB33194

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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